ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation
NCT ID: NCT04702360
Last Updated: 2021-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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ELX/TEZ/IVA
Fixed-dose combination tablet for oral administration.
IVA
IVA monotablet for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior treatment for at least 6 months with an approved alternative CFTR modulator (if the patient is eligible for such treatment)
* Patients with percent predicted forced expiratory volume in 1 second (ppFEV1) \<40 for a minimum of 60 consecutive days before the date of completion of the request form
Exclusion Criteria
6 Years
11 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Other Identifiers
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VX20-445-905
Identifier Type: -
Identifier Source: org_study_id
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